Healthy Volunteers1380GCCNCT02700776
1380GCC: Prospective Study of GP-88 Blood Test in Healthy Women With Baseline Gail Model Risk Assessment Undergoing Screening for Breast Cancer
An observational study of Healthy Volunteers, run by University of Maryland, Baltimore at 2 sites in United States.
Trial summary
The purpose of this study is find out if a protein level in the blood (called PC Cell Derived Growth Factor or glycoprotein 88 [GP88]), combined with standard mammography screening, can help detect breast cancer better than mammography screening alone. Read more about this study
- Who is it for?
- Ages 40 to 64 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Phlebotomy - Blood sampling for GP88 at MM and SOC Tissue biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 417 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2014to 27 Feb 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 64 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Prospectively determine the GP-88 blood levels in healthy female volunteers who are undergoing routine screening mammography.
Who may be able to join
- Female greater than or equal to 40 years.
- Presenting to UM Breast Center and BWMC for breast imaging: screening or diagnostic mammogram, breast ultrasound (US), breast MRI, stereotactic core needle biopsy, ultrasound core needle biopsy, MRI guided breast biopsy.
- Patients with a recent screening diagnosis of breast cancer < = 3months.
- Patients presenting with mammogram findings with BIRADS of 0-6 < =3 months.
- Able to understand and the willingness to sign a written informed consent document.
Who cannot join
- Patients with a personal history of stage 0-4 breast cancer >3months.
- Patients who have known severe and/or uncontrolled medical or psychiatric conditions or other conditions that could affect their participation in the study, or personal history of other malignancies.
- Patients who are unfit or unable to comply with having breast imaging studies such as mammogram, ultrasound, and MRI or breast biopsy or with study procedures-blood draw.
- Patients with personal history of ovarian cancer or other cancers.
- Patients with a personal history of breast biopsy positive for atypical ductal hyperplasia (ADH), atypical lobular hyperplasia (ALH), lobular carcinoma in situ (LCIS).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Maryland, Greenebaum Cancer Center
Baltimore, Maryland, 21201
Baltimore Washington Medical Center
Glen Burnie, Maryland, 21061
About this study
The purpose of this study is find out if a protein level in the blood (called PC Cell Derived Growth Factor or glycoprotein 88 [GP88]), combined with standard mammography screening, can help detect breast cancer better than mammography screening alone. Earlier research has shown that a certain glycoprotein 88 (GP88) is higher in women with breast cancer.
In this study, investigators will measure the level of GP88 in the blood of healthy women who are having mammography screening for breast cancer. The investigator plans to correlate the results of the mammogram with the GP-88 level.
Read the detailed description
Eligible healthy women >= 40 years old at average risk for developing breast cancer will be offered participation in the study at the time they present for routine screening mammogram (MM) at the University of Maryland Breast Screening Center and Baltimore Washington Medical Center; includes women who present to the center as a referral for further diagnostic workup of recent screening diagnosis of breast cancer <= to 3 months with mammographic findings on screening MM with BIRADS 0-6<= 3 months.
Informed consent will be reviewed with the study participant and She will be asked if She wishes to participate in this study. Once the volunteer agrees and signs the consent, her eligibility criteria will be reviewed by the study coordinator and if eligible the patient will be enrolled. Her MM, US or MRI results will be obtained and the study subject will be assigned to one of the 3 cohorts of patients.
COHORT I-BIRADS 1 or 2, COHORT II -BIRADS 3 COHORT III-BIRADS 4-6.
The first blood sample (20ml) for GP-88 will be drawn within 31 days of the initial signing of the informed consent. It is expected that majority of women attending the screening and diagnostic program at the UM Breast Center will be approached about this study. The investigator expects to screen 1400 and consent approximately 800 women in 12 months.
Once deemed eligible the study participant will have their first GP-88 blood sample drawn (20ml) within 31 days of signing the consent. The investigator will make every effort to draw the blood sample for GP-88 on the day of the visit to our breast center and will try not to ask study participants to come back to have the blood samples drawn unless the patient is willing to do it. However the study participant does have the option to have the GP-88 blood sample drawn within 31 days of her screening or diagnostic MM, US or breast MRI or biopsy if she wishes to participate but cannot do it on the day of her visit here. If the initial-first blood sample is never drawn the patient will be considered a screen failure, if subsequent blood samples will not be drawn or if the patient does not return for follow up screening or diagnostic MM or other testing as recommended by the radiologists, she will be replaced by another subject.
- Conditions
- Healthy Volunteers
- Being tested
- Phlebotomy - Blood sampling for GP88 at MM, SOC Tissue biopsy
- Keywords
- screening mammogram, GP88, breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phlebotomy - Blood sampling for GP88 at MMOther
Also called GP88
Women undergoing a screening mammogram will have a blood sample drawn to look for GP88.
SOC Tissue biopsyProcedure or surgery
standard of care tissue biopsy if clinically indicated.
| Study group | Role | What they receive |
|---|---|---|
| COHORT I-BIRADS 1 or 2, | Phlebotomy - Blood sampling for GP88 and MM. Occurs at months 0 and 6-12. Receives: Other: Phlebotomy - Blood sampling for GP88 at MM | |
| COHORT II -BIRADS 3 | Phlebotomy - Blood sampling for GP88 and MM. Occurs at months 0, 3-6, and 6-12. Receives: Other: Phlebotomy - Blood sampling for GP88 at MM | |
| COHORT III-BIRADS 4-6 | SOC Tissue Biopsy. Occurs at months 0, 3-6, and 6-12. Receives: Other: Phlebotomy - Blood sampling for GP88 at MM; Procedure: SOC Tissue biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the GP-88 blood levels in healthy female volunteers who are undergoing routine screening mammography
- To prospectively determine the GP-88 blood levels in healthy female volunteers who are undergoing routine screening mammography at the UM Breast Center, Baltimore Washington Medical Center and other local breast imaging referral centers and in patients with biopsy-confirmed breast cancer.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2016 (estimated)
- Study startApr 2014
- Primary completion27 Feb 2017
- Study completion27 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 417 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- A&G Pharmaceutical
- Responsible party
- Sponsor
- Investigators
- Katherine Tkaczuk, MD, Principal investigator, University of Maryland Greenebaum Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02700776
- Sponsor's protocol ID
- HP-00058144 1380GCC
- Acronym
- 1380GCC
- Status last verified
- Nov 2019
- First submitted
- 1 Mar 2016
- Last updated
- 7 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 1380GCC: Prospective Study of GP-88 Blood Test in Healthy Women With Baseline Gail Model Risk Assessment Undergoing Screening for Breast Cancer
- ClinicalTrials.gov ID
- NCT02700776
- Acronym / sponsor ID
- 1380GCC / HP-00058144 1380GCC
- Conditions
- Healthy Volunteers
- Keywords
- screening mammogram, GP88, breast cancer
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 417 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- A&G Pharmaceutical
- Study start
- Apr 2014 (actual)
- Primary completion
- 27 Feb 2017 (actual)
- Study completion
- 27 Feb 2017 (actual)
- First posted
- 7 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is find out if a protein level in the blood (called PC Cell Derived Growth Factor or glycoprotein 88 [GP88]), combined with standard mammography screening, can help detect breast cancer better than mammography screening alone. Earlier research has shown that a certain glycoprotein 88 (GP88) is higher in women with breast cancer.
In this study, investigators will measure the level of GP88 in the blood of healthy women who are having mammography screening for breast cancer. The investigator plans to correlate the results of the mammogram with the GP-88 level.
Detailed description
Eligible healthy women >= 40 years old at average risk for developing breast cancer will be offered participation in the study at the time they present for routine screening mammogram (MM) at the University of Maryland Breast Screening Center and Baltimore Washington Medical Center; includes women who present to the center as a referral for further diagnostic workup of recent screening diagnosis of breast cancer <= to 3 months with mammographic findings on screening MM with BIRADS 0-6<= 3 months.
Informed consent will be reviewed with the study participant and She will be asked if She wishes to participate in this study. Once the volunteer agrees and signs the consent, her eligibility criteria will be reviewed by the study coordinator and if eligible the patient will be enrolled. Her MM, US or MRI results will be obtained and the study subject will be assigned to one of the 3 cohorts of patients.
COHORT I-BIRADS 1 or 2, COHORT II -BIRADS 3 COHORT III-BIRADS 4-6.
The first blood sample (20ml) for GP-88 will be drawn within 31 days of the initial signing of the informed consent. It is expected that majority of women attending the screening and diagnostic program at the UM Breast Center will be approached about this study. The investigator expects to screen 1400 and consent approximately 800 women in 12 months.
Once deemed eligible the study participant will have their first GP-88 blood sample drawn (20ml) within 31 days of signing the consent. The investigator will make every effort to draw the blood sample for GP-88 on the day of the visit to our breast center and will try not to ask study participants to come back to have the blood samples drawn unless the patient is willing to do it. However the study participant does have the option to have the GP-88 blood sample drawn within 31 days of her screening or diagnostic MM, US or breast MRI or biopsy if she wishes to participate but cannot do it on the day of her visit here. If the initial-first blood sample is never drawn the patient will be considered a screen failure, if subsequent blood samples will not be drawn or if the patient does not return for follow up screening or diagnostic MM or other testing as recommended by the radiologists, she will be replaced by another subject.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| COHORT I-BIRADS 1 or 2, | – | Other: Phlebotomy - Blood sampling for GP88 at MMPhlebotomy - Blood sampling for GP88 and MM. Occurs at months 0 and 6-12. |
| COHORT II -BIRADS 3 | – | Other: Phlebotomy - Blood sampling for GP88 at MMPhlebotomy - Blood sampling for GP88 and MM. Occurs at months 0, 3-6, and 6-12. |
| COHORT III-BIRADS 4-6 | – | Other: Phlebotomy - Blood sampling for GP88 at MM, Procedure: SOC Tissue biopsySOC Tissue Biopsy. Occurs at months 0, 3-6, and 6-12. |
Who may qualify
- Ages
- 40 to 64 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Prospectively determine the GP-88 blood levels in healthy female volunteers who are undergoing routine screening mammography.
Key inclusion criteria (5 listed)
- Female greater than or equal to 40 years.
- Presenting to UM Breast Center and BWMC for breast imaging: screening or diagnostic mammogram, breast ultrasound (US), breast MRI, stereotactic core needle biopsy, ultrasound core needle biopsy, MRI guided breast biopsy.
- Patients with a recent screening diagnosis of breast cancer < = 3months.
- Patients presenting with mammogram findings with BIRADS of 0-6 < =3 months.
- Able to understand and the willingness to sign a written informed consent document.
Key exclusion criteria (5 listed)
- Patients with a personal history of stage 0-4 breast cancer >3months.
- Patients who have known severe and/or uncontrolled medical or psychiatric conditions or other conditions that could affect their participation in the study, or personal history of other malignancies.
- Patients who are unfit or unable to comply with having breast imaging studies such as mammogram, ultrasound, and MRI or breast biopsy or with study procedures-blood draw.
- Patients with personal history of ovarian cancer or other cancers.
- Patients with a personal history of breast biopsy positive for atypical ductal hyperplasia (ADH), atypical lobular hyperplasia (ALH), lobular carcinoma in situ (LCIS).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phlebotomy - Blood sampling for GP88 at MMAlso: GP88Women undergoing a screening mammogram will have a blood sample drawn to look for GP88. | Other | COHORT I-BIRADS 1 or 2,, COHORT II -BIRADS 3, COHORT III-BIRADS 4-6 |
| SOC Tissue biopsystandard of care tissue biopsy if clinically indicated. | Procedure or surgery | COHORT III-BIRADS 4-6 |
Primary outcome
Determine the GP-88 blood levels in healthy female volunteers who are undergoing routine screening mammography
Time frame: 12 months
1. To prospectively determine the GP-88 blood levels in healthy female volunteers who are undergoing routine screening mammography at the UM Breast Center, Baltimore Washington Medical Center and other local breast imaging referral centers and in patients with biopsy-confirmed breast cancer.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katherine Tkaczuk, MD principal investigator
University of Maryland Greenebaum Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Volunteers, run by University of Maryland, Baltimore at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the GP-88 blood levels in healthy female volunteers who are undergoing routine screening mammography (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2019.